Medicare Reimbursement for an Artificial Iris



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Q  What is the CUSTOMFLEX® ARTIFICIALIRIS from VEO Ophthalmics?

A  The CUSTOMFLEX ARTIFICIALIRIS is a silicone disc to replace a missing or damaged iris.1 The disc diameter measures 12.80 mm with a fixed 3.35 mm diameter pupil. The device is custom made for each patient; colorized silicone is applied to the front surface to simulate natural iris from a template photograph. The back surface is black for maximum light-blocking. Because eyes vary in size, it may be cut at the time of surgery for proper fit. The artificial iris can be placed with or without sutures. The device is available in two models: 1) With Fiber, and 2) Fiber Free. With Fiber has an embedded polyester meshwork for added strength to withstand suturing.


Q  What is the FDA status of the device?

A  It was granted premarket approval by the FDA in May 2018.2 Additionally, FDA designated it a humanitarian use device in 2010.


Q  What are the indications for use?

A  It is for treatment of iris defects.3 It is indicated for use in children and adults for the treatment of full or partial aniridia resulting from congenital aniridia, acquired defects, or other conditions associated with full or partial aniridia such as albinism.


Q  How is the artificial iris implanted?

A  The CUSTOMFLEX ARTIFICIALIRIS can be cut to a size that will fit a specific capsular bag or ciliary sulcus with a trephine. It can be implanted in addition to or at the same time as most commercially available IOLs with the exception of active accommodating IOLs. It is flexible, allowing it to be folded and inserted manually using forceps or injected using the AMO [now J&J Vision] silver series IOL injector. The device can be implanted using a sutured or sutureless technique. It can be used for either intracapsular, sulcus, or suture fixation, depending on pre-existing anatomy and the evolution of the individual patient’s surgical procedure. Furthermore, secondary suture fixation is possible late after the primary procedure in case progressive zonulopathy causes dislocation of the device.


Q  Will Medicare cover the artificial iris and its implantation?

A  Yes. The treatment of aniridia with an FDA approved device meets the statutory coverage criteria of the Medicare program for “the diagnosis and treatment of illness or injury or to improve the functioning of a malformed body member.”4 Other third party payers generally agree with this policy.


Q  What CPT code is used to report implantation?

A  At present, there are limited choices.

  • Use 66999 (Unlisted procedure, anterior segment of eye) to report insertion of artificial iris prosthesis in an aphakic or pseudophakic eye
  • Use 66982 (Complex cataract) for insertion of artificial iris and concurrent cataract removal and IOL implantation

In some cases, particularly after trauma, other ophthalmic procedures may be performed concurrently with implantation of an artificial iris; these might include vitrectomy, keratoplasty, McCannel suture, or repair of laceration.


Q  What HCPCS code describes this prosthetic device?

A  The ASC or HOPD will use HCPCS C1889 (Implantable/insertable device, not otherwise classified) to identify this supply. At the present time, there is no unique HCPCS code for this prosthetic device. On the UB-04 claim form, use revenue code 278 (other implant).


Q  How does Medicare reimburse the surgeon?

A  For a specific CPT code, such as 66982, the Medicare Physician Fee Schedule (MPFS) applies. For a miscellaneous code, such as 66999, the MPFS does not specify a payment amount and that determination is made by the Medicare Administrative Contractor on an individual case-by-case basis. The surgeon does not bill for the artificial iris; the ASC or HOPD does.


Q  What is the Medicare payment to the facility?

A  Under the Medicare Outpatient Prospective Payment System (OPPS), 66999 and 66982 are included in a comprehensive ambulatory payment classification, C-APC 5491. Status indicator J1 is assigned, which means there is a single payment for a C-APC. For the HOPD, the allowed amount is $1,917. For an ASC, there is no payment for 66999; $977 is allowed for 66982.

There is no separate payment for the artificial iris. C1889 is assigned the status indicator “N” in the HOPD meaning “payment is packaged into payment for other services” and not separately paid. For the ASC, the “N1” indicator is assigned which means “packaged service/no separate payment made.”4

An Advance Beneficiary Notice may not be used to circumvent the OPPS package payment. Other third party payers make their own payment rules; check with the payer prior to surgery.


1 Human Optics CustomFlex Artificial Iris. Link here.
2 US FDA Premarket Approval P170039 Link here.
3 Directions for Use. Contraindications. Link here.
4 Social Security Act 1862(a)


Provided Courtesy of Veo Ophthalmics  (513) 872-1330

Last updated February 24, 2017


The reimbursement information is provided by Corcoran Consulting Group based on publicly available information from CMS, the AMA, and other  sources. The reader is strongly encouraged to review federal and state laws, regulations, code sets, and official instructions promulgated by  Medicare and other payers. This document is not an official source nor is it a complete guide on reimbursement. Although we believe this
information is accurate at the time of publication, the reader is reminded that this information, including references and hyperlinks, changes over time, and may be incorrect at any time following publication.

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